A Study of LY4257496 in Participants With Cancer (OMNIRAY)
NCT ID: NCT07114601
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
421 participants
INTERVENTIONAL
2025-08-06
2035-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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LY4257496 Phase 1a Dose Escalation (Cohort A1)
LY4257496 administered intravenously (IV)
LY4257496
Administered IV
LY4257496 Phase 1a Dose Optimization (Cohort A2)
LY4257496 administered IV
LY4257496
Administered IV
LY4257496 + Standard of Care Phase 1b Cohort B
Tumor specific cohort will receive LY4257496 alone or with standard of care anticancer therapy(ies)
LY4257496
Administered IV
Standard of Care Anticancer Therapies
Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, Abemaciclib
LY4257496 Phase 1b Cohort C
Tumor specific cohort will receive LY4257496
LY4257496
Administered IV
LY4257496 Phase 1b Cohort D
Tumor specific cohort will receive LY4257496
LY4257496
Administered IV
Interventions
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LY4257496
Administered IV
Standard of Care Anticancer Therapies
Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, Abemaciclib
Eligibility Criteria
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Inclusion Criteria
* Must be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) to confirm at least 1 of the following:
* At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* If only bone lesions are present without a soft-tissue component, a bone scan or MRI must confirm at least 2 detectable lesions considered to represent active metastases
* Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging.
* Must have the following histologically or cytologically confirmed diagnosis:
* Estrogen receptor (ER+)/human epidermal growth factor receptor 2 (HER2-) breast cancer
* ER+/HER2+ breast cancer
* Colorectal carcinoma
* Metastatic castration-resistant prostate cancer
* Endometrial carcinoma
* Other GRPR-positive solid tumor
* For participants with breast cancer diagnosis, where possible, ER and HER2 status should be assessed from the most recent tissue biopsy taken at the time of presentation with recurrent or metastatic disease.
* To fulfill the requirement for ER+ disease by local testing, a tumor must express the ER immunohistochemistry, as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
* HER2 status should be determined by local testing, as defined in the relevant ASCO/CAP Guidelines.
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1.
* Must be able to comply with outpatient treatment, laboratory monitoring, imaging, and required clinic visits for the duration of trial participation.
Exclusion Criteria
* Has a history of ongoing acute pancreatitis within 1 year of screening.
* Previously received any prior hemi-body or whole-body radiotherapy, or prior external beam radiation therapy (EBRT) to greater than 25% of the bone marrow.
* A bone superscan, defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity.
* Has evidence of ongoing and untreated urinary tract obstruction or unmanageable urinary incontinence.
* Has known active hepatitis B virus (HBV) (screening for HBV is not required for individuals who do not have a history of HBV, unless required by local regulations). Individuals with treated/chronic HBV are eligible for the trial provided they meet the following criteria:
* Individuals with positive hepatitis B surface antigen (HBsAg) must be on permitted suppressive antiviral therapy prior to C1D1, remain on the same antiviral treatment throughout trial, and should follow local standards for continuation of therapy after completion of trial therapy.
* Undetectable HBV deoxyribonucleic acid (DNA) less than or equal to 28 days of C1D1.
* Has known active hepatitis C virus (HCV) (screening for HCV is not required for individuals who do not have a history of HCV unless required by local regulations). Individuals previously treated for HCV are eligible for the trial provided they meet the following criteria:
* Completion of curative antiviral therapy.
* HCV viral load below the limit of quantification less than or equal to 28 days of C1D1.
* Negative hepatitis C antibody result OR, if positive, then must be hepatitis C RNA negative.
* Has known untreated human immunodeficiency virus (HIV) infection (screening for HIV is not required unless required by local regulations). Participants on permitted antiretroviral therapy (ART) and who have well-controlled HIV infection/disease are eligible provided they meet the following criteria:
* Must be on a stable and permitted ART regimen without changes in drug or dose, for at least 4 weeks prior to C1D1 and have a viral load of \<400 copies per mL prior to less than or equal to 28 days of C1D1.
* CD4+ T-cell count greater than or equal to 350 cells/uL less than or equal to 28 days of C1D1.
* Has an active second malignancy unless in remission with life expectancy greater than 2 years.
* Has known hypersensitivity to any component or excipient of LY4257496.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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City of Hope
Duarte, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
Biogenix Molecular, LLC
Miami, Florida, United States
Emory University School of Medicine - Winship Cancer Institute
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
BAMF Health Inc.
Grand Rapids, Michigan, United States
Washington University
St Louis, Missouri, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
Texas Oncology - DFW (Sammons CC)
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Juravinski Cancer Centre
Hamilton, , Canada
Lady Davis Institute for Medical Research Jewish General Hospital
Montreal, , Canada
Sunnybrook Health Sciences Centre
Toronto, , Canada
Princess Margaret Hospital
Toronto, , Canada
Institut de Cancerologie de l'Ouest - site St-Herblain
Saint-Herblain, , France
Universitaetsklinikum Essen
Essen, , Germany
LMU Klinikum Muenchen-Campus Grosshadern
München, , Germany
Hospital Universitari Quiron Dexeus Barcelona
Barcelona, , Spain
Countries
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Central Contacts
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role: CONTACT
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Role: CONTACT
Related Links
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A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Other Identifiers
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J6C-OX-JKFA
Identifier Type: OTHER
Identifier Source: secondary_id
27354
Identifier Type: -
Identifier Source: org_study_id
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